Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06257069
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tremor Retrainer Software Application for Functional Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003291', 'term': 'Conversion Disorder'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-01-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence', 'timeFrame': 'Study visit 3', 'description': 'Duration of sessions completed'}, {'measure': 'Clinical Global Impression Severity Scale - Clinician Rated', 'timeFrame': 'Study visits 1-4', 'description': 'Clinician rated impression of tremor severity. Score range: 1-7, with 7 being most severely affected'}, {'measure': 'Clinical Global Impression Improvement Scale - Clinician Rated', 'timeFrame': 'Study visits 2-4', 'description': 'Clinician rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.'}, {'measure': 'Clinical Global Impression Improvement Scale - Patient Rated', 'timeFrame': 'Study visits 2-4', 'description': 'Patient rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Between study visits 2-3', 'description': 'Patient rated impression of tremor severity. Score range: 0-10, with 10 being worst tremor imaginable.'}, {'measure': '36-Item Short-Form Survey', 'timeFrame': 'Study visits 1 and 4', 'description': 'Quality of life scale. Score range: 0-100, with 100 being best.'}], 'primaryOutcomes': [{'measure': 'mHealth Application Usability Questionnaire', 'timeFrame': 'Study visit 3', 'description': 'Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability'}, {'measure': 'Simplified Functional Movement Disorder Rating Scale', 'timeFrame': 'Study visits 1-4', 'description': 'Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Tremor'], 'conditions': ['Functional Movement Disorder', 'Functional Neurological Disorder', 'Functional Neurological Symptom Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are:\n\n1. Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?\n2. Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?', 'detailedDescription': 'Following a one-week observation period, 20 subjects will complete the one-week four hour Tremor Retrainer smartphone protocol.\n\nThe study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1.\n\nFor Objective 1, the investigators will evaluate mHealth Application Usability Questionnaire scores after subjects complete Tremor Retrainer protocol and compare Simplified Functional Movement Disorder Rating Scale (S-FMDRS) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups.\n\nFor Objective 2, the investigators will evaluate which components can be scored after televideo administration of S-FMDRS and measure correlation between randomly-ordered sequential in-person and televideo S-FMDRS administration.\n\nFor Objective 3, the investigators will measure change and variability in S-FMDRS between study visit 1 and 2. S-FMDRS scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 10 years and older, any gender, any race\n2. Functional tremor as defined by Espay and Lang25, diagnosed by a movement disorders neurologist, involving at least 1 arm and ongoing at time of enrollment.\n3. Access to internet and a laptop or tablet with a videocamera.\n4. Informed consent obtained and signed\n5. Subject understands study procedures and is able to comply with study procedures for duration of study\n\nExclusion Criteria:\n\n1. Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor\n2. Cognitive impairment with previously diagnosed intellectual disability (IQ\\<70) or dementia\n3. Hearing impairment not addressed by hearing aids\n4. Prior enrollment in clinical trial involving the Tremor Retrainer application"}, 'identificationModule': {'nctId': 'NCT06257069', 'briefTitle': 'Tremor Retrainer Software Application for Functional Tremor', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Tremor Retrainer Software Application for Functional Tremor', 'orgStudyIdInfo': {'id': '230161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'All subjects will receive intervention with Tremor Retrainer smartphone application', 'interventionNames': ['Device: Tremor Retrainer Smartphone Application']}], 'interventions': [{'name': 'Tremor Retrainer Smartphone Application', 'type': 'DEVICE', 'description': "The Tremor Retrainer smartphone application uses the smartphone's built-in accelerometer to calculate a patient's tremor frequency when the smartphone is strapped to the patient's wrist. The application will provide auditory cues to the patient with a treatment frequency at 2/3 the patient's baseline tremor frequency for half a session, then 1/3 the patient's baseline tremor frequency for the second half of the session. Meanwhile, oscillatory movements will be continuously analyzed with frequency calculated and displayed relative to goal frequency, so that the patient receives continuous feedback via a visual dial as to whether they are meeting treatment goals. Intervention will consist of a one-week Tremor Retrainment Protocol.", 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah Caballero, LCSW', 'role': 'CONTACT', 'email': 'HTP5AW@uvahealth.org', 'phone': '434-297-5711'}, {'name': 'Jordan Garris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Hannah Caballero, LCSW', 'role': 'CONTACT', 'email': 'HTP5AW@uvahealth.org', 'phone': '434-297-5711'}], 'overallOfficials': [{'name': 'Jordan Garris', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'url': 'https://www.ithriv.org/ithriv-research-data-commons', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data anticipated to be available in 2026.', 'ipdSharing': 'YES', 'description': 'Anonymized participant data, including raw scores of outcome measures will be available for review.', 'accessCriteria': 'Anonymized participant data will be publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Child Neurology Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jordan F Garris', 'investigatorAffiliation': 'University of Virginia'}}}}